The Comparative Efficacy of Focused Extracorporeal Shockwave Therapy and Dry Needling Among Patients With Myofascial Pain Syndrome of the Upper Trapezius Muscle, a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
Myofascial pain syndrome (MPS) is one of the most common causes of musculoskeletal pain. Among patients with MPS, the upper trapezius muscle appears to be the common muscle that generates pain in the area of upper extremity. The main target treatment for MPS is to eradicate the painful trigger points by using treatment options, such as ultrasound, laser, and dry needling (DN). In the past decade, focused extracorporeal shockwave therapy (fESWT) has become the well-known treatment for pain relief in various musculoskeletal pain conditions. The main advantages of this non-invasive treatment modality are reducing pain, inflammation and promoting tissue healing. However, there were no previous studies compared effects of fESWT to dry needling. Therefore, the present study aims to compare the efficacy of the two treatments in terms of pain reduction and functional improvement.
详细描述
- This study is a single-blinded non-inferiority randomized controlled trial that will compare the efficacy of fESWT to DN in terms of pain reduction and functional improvement in patients with MPS of the upper trapezius.
- 58 patients will be recruited for the study and randomly allocated to 2 groups, mainly fESWT and DN.
- For the fESWT group, the participants will receive fESWT once a week, for a total of 3 sessions, consecutively. While the participants in the DN group will receive DN at the painful trigger point for 1 session. Moreover, both groups will receive the same conservative treatment, for example, education, exercise, and behavioral modification advice.
- The primary outcome is Visual Analogue Scale (VAS) and the secondary outcomes are Pain Pressure Threshold (PPT) and Neck Disability Index (NDI) which will be recorded at baseline, 1 week, 3 week, and 6 week from baseline.
- Statistical analysis will be performed using Stata to detect statistically significant changes in the same group and differences between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant who is diagnosed with myofascial pain syndrome based on the criteria listed below:
- •The trigger point must be in a taut band of the upper trapezius muscle. The trigger point in the muscle is hypersensitivity to pain. Pain radiates to the specific pattern of the upper trapezius muscle. When pressure is applied to the trigger point, the participant perceives the same pain sensation as their pain complaint.
- •The participant who has a VAS score of > or = 5 points
- •The participant who has had myofascial pain for > or = 3 months
排除标准
- •The participant who has
- •Unresolved neurological or musculoskeletal problems, such as fibromyalgia, cervical radiculopathy, and cervical spine fracture.
- •History of cervical spine or shoulder surgery
- •Uncontrolled underlying diseases, such as psychological problems, cancer, or acute renal or hepatic failure
- •Received treatment by other physical modalities or steroid injection into the trigger point within 3 months, or was treated by analgesic drugs within 2 weeks.
- •Contraindicated to ESWT or DN
- •Refuse to attend the study
研究组 & 干预措施
Focused Extracorporeal Shockwave Therapy (fESWT)
The participant will be treated by fESWT plus conservative treatment. fESWT will be applied once a week, for a total of 3 sessions.
干预措施: Focused Extracorporeal Shockwave Therapy (fESWT) (Device)
Dry needling (DN)
The participant will be treated by DN plus conservative treatment. DN will be done as a single session.
干预措施: Dry needling (DN) (Other)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Changes in VAS were assessed at baseline, and at 4 and 6 weeks following baseline.
VAS is a subjective tool that is used to measure pain scores. In this study, the 100-numerical scale will be used, in which 0 means "no pain," whereas 100 means "the worst pain." Patients mark the scale to rate the pain score based on their pain perception.
次要结局
- Pain pressure threshold (PPT)(Changes in PPT were assessed at baseline, and at 4 and 6 weeks following baseline.)
- The Neck Disability Index (NDI)(Changes in NDI were assessed at baseline and 6 weeks following baseline.)